Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects

This study has been terminated.

Sponsor:

Collaborator:

Human Genome Sciences Inc., a GSK Company

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00964665

First received: August 24, 2009

Last updated: January 5, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 24, 2009

Last Updated Date

January 5, 2011

Start Date ^ICMJE

July 2009

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00964665 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects

Official Title ^ICMJE

A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.

Brief Summary

This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis B

Intervention ^ICMJE

Drug: albinterferon alfa-2b
Drug: Pegasys®

Study Arm (s)

Experimental: Group 1 ABF656 900ug Q2w
Intervention: Drug: albinterferon alfa-2b
Experimental: Group 2 ABF656 900ug Q4w
Intervention: Drug: albinterferon alfa-2b
Experimental: Group 3 AB656 1200ug Q4w
Intervention: Drug: albinterferon alfa-2b
Experimental: Group 4 ABF656 1500ug Q4w
Intervention: Drug: albinterferon alfa-2b
Active Comparator: Group 5 Pegasys® 180µg qw
Intervention: Drug: Pegasys®

Publications *

Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

141

Completion Date

Not Provided

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
Chronic HBV infection (serum HBsAg detectable for > 6 months)
Serum HBeAg positive with HBV DNA >106copies/mL (or >200,000 IU/mL)
Serum ALT must be > 2 x ULN but below 10 x ULN

Exclusion Criteria:

Steroid treatment or immunosuppression 3 months prior to entry.
Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
Hb< 10g/dL or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 .
Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
History of hypothyroidism or current treatment for thyroid disease.
Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China, Hong Kong, Poland, Taiwan, Thailand

Administrative Information

NCT Number ^ICMJE

NCT00964665

Other Study ID Numbers ^ICMJE

CABF656A2206, EudraCT 2008-006933-29

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Human Genome Sciences Inc., a GSK Company

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Novartis Institute for Biomedical Research

Information Provided By

Novartis

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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